{
  "abstract": "Objectives To assess the feasibility of delivering the swallowing prehabilitation intervention known as Swallowing Intervention Package: Self-Monitoring, Assessment and Rehabilitation Training (SIP SMART) within the National Health Service (NHS) head and neck cancer care pathway.Design Two-arm cluster-randomised pilot trial: SIP SMART2 trial.Setting and participants Adults newly diagnosed with stage II–IV head and neck cancer receiving curative treatment within a multidisciplinary team who agree to participate.Interventions Six hospitals were randomised. Trained clinicians at the intervention sites delivered the manualised SIP SMART intervention, while standard care was provided at care as usual (CAU) sites. The intervention included two 45-minute consultations incorporating an X-ray swallow assessment, tailored exercises/advice and specific behaviour change strategies while CAU involved a single consultation of information giving and provision of a generic exercise sheet.Outcomes Study outcomes related to feasibility of the cluster-randomised design, recruitment of both sites and patients and completeness of clinical and health economic data collected at baseline, 4 weeks, 12 weeks and 24 weeks after treatment.Results 12 hospitals expressed interest and six were randomised (50%) and provided data to the point of study completion. Patient recruitment across all sites (n=76) reached the target, although two sites fell short of their individual targets. The proportion of people with HNC recruited versus those eligible for each arm was 39% (95% CI 29 to 49) for SIP SMART group and 55% (95% CI 43 to 66) for CAU. The end point data at 24 weeks were completed for 50% (95% CI 33 to 67) for SIP SMART and 78% (95% CI 62 to 89) for CAU. Adherence to the intervention was above 50% at all time points. No harms related to the intervention were reported.Conclusions It is feasible to deliver the SIP SMART intervention embedded within the NHS cancer care pathway using a cluster-randomised design. A future trial will be optimised for efficiency in set-up and follow-up data collection based on these findings and learnings from the accompanying process evaluation study.Trial registration number ISRCTN12377415.",
  "authors": [
    {
      "affiliations": [
        "Head and Neck Academic Centre, Division of Surgery & Interventional Science, University College London, London, UK",
        "Head and Neck Cancer Centre, University College London Hospitals NHS Foundation Trust, London, UK"
      ],
      "name": "Roganie Govender"
    },
    {
      "affiliations": [
        "Department of Primary Care and Population Health, University College London, London, UK"
      ],
      "name": "Jiunn Wang"
    },
    {
      "affiliations": [
        "University College London, London, UK",
        "Priment Clinical Trials unit, University College London, London, UK"
      ],
      "name": "Louise Marston"
    },
    {
      "affiliations": [
        "Department of Primary Care and Population Health, University College London, London, UK"
      ],
      "name": "Elena Pizzo"
    },
    {
      "affiliations": [
        "Centre for Medical Imaging, University College London Hospitals NHS Foundation Trust, London, UK"
      ],
      "name": "Stuart Taylor"
    },
    {
      "affiliations": [
        "Department of Primary Care and Population Health, University College London, London, UK",
        "Priment Clinical Trials unit, University College London, London, UK"
      ],
      "name": "Irwin Nazareth"
    }
  ],
  "title": "Swallowing prehabilitation for people with head and neck cancer: a pilot cluster-randomised feasibility trial of the SIP SMART intervention",
  "uid": "f4dcda7f-42bb-59fd-8159-5f4ff852b2b2"
}